On February 27, 2023 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the fourth quarter and full fiscal year ended December 31, 2022 (Press release, ViewRay, FEB 27, 2023, View Source [SID1234627773]).

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Full Year 2022 Highlights

Total revenue of $102.2 million primarily from 16 revenue units including one upgrade, compared to 2021 revenue of approximately $70.1 million, primarily from ten revenue units.
Received a total of 32 orders for the twelve months ended December 31, 2022, totaling $191.0 million, compared to 28 total orders totaling $158.9 million in 2021.
Total backlog increased to approximately $380.2 million as of December 31, 2022, compared to approximately $313.4 million as of December 31, 2021.
Cash and cash equivalents was approximately $142.5 million as of December 31, 2022. Cash usage in 2022 was $91.2 million excluding the term loan net proceeds from the November debt restructuring.
Fourth Quarter 2022 Highlights

Total revenue for the fourth quarter 2022 was approximately $34.7 million, primarily from five revenue units, compared to approximately $20.4 million, primarily from three revenue units, in the fourth quarter of 2021.
Received nine new orders for MRIdian systems totaling approximately $56.4 million, compared to seven new orders totaling approximately $40.7 million in the fourth quarter of 2021.
"Our innovation and clinical pipelines, along with increased market awareness efforts, are driving therapy adoption," said Scott Drake, President and CEO. "Over 29,000 patients have been treated to date, it’s clear that when patients know highly-effective, short-course, virtually side-effect-free therapy is available, they will demand it and travel for it. We focus on our mission of "Treating and proving what others can’t" which position us to drive revenue growth, gross margin expansion, and expense leverage again in 2023."

Financial Results

Total revenue for the three months ended December 31, 2022 was $34.7 million compared to $20.4 million for the same period last year. Total revenue for the full year 2022 was $102.2 million compared to $70.1 million for the full year 2021.

Total cost of revenue for the three months ended December 31, 2022 was $30.3 million compared to $20.6 million for the same period last year. Total cost of revenue was $92.2 million for the full year 2022 compared to $69.8 million for the full year 2021.

Total gross profit for the three months ended December 31, 2022 was $4.4 million, compared to a gross loss of $0.2 million for the same period last year. Total gross profit for the full year 2022 was $10.0 million compared to gross profit of $0.3 million for the full year 2021.

Total operating expenses for the three months ended December 31, 2022 were $30.4 million, compared to $29.0 million for the same period last year. Total operating expenses for the full year 2022 were $117.2 million compared to $104.0 million for the full year 2021.

Net loss for the three months ended December 31, 2022 was $27.8 million, or $(0.15) per share, compared to $27.1 million, or $(0.16) per share, for the same period last year. Net loss for the full year 2022 was $107.3 million, or $(0.59) per share, compared to $110.0 million, or $(0.67) per share, for the full year 2021.

Non-GAAP adjusted EBITDA for the three months ended December 31, 2022 was a loss of $18.4 million, compared to a loss of $24.1 million for the same period last year. Non-GAAP adjusted EBITDA for the full year 2022 was a loss of $78.2 million compared to a loss of $73.7 million for the full year 2021. We define adjusted EBITDA as EBITDA (defined as net income before net interest expense, depreciation, and amortization), adjusted for impairment of assets, non-cash equity-based compensation, non-cash changes in warrant liability valuations, and non-recurring costs. Refer to the schedule below for a reconciliation of GAAP net loss (the most directly comparable GAAP measure) to non-GAAP adjusted EBITDA.

ViewRay had total cash and cash equivalents of $142.5 million at December 31, 2022.

Financial Guidance

For the full year 2023, ViewRay anticipates total revenue will increase 25% to 40% and Adjusted EBITDA to be in the range of $(70 million) to $(80 million). Our definition of adjusted EBITDA is set forth above. Refer to the schedule below for a reconciliation of GAAP net loss (the most directly comparable GAAP measure) to non-GAAP adjusted EBITDA.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Monday, February 27, 2023 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in number is (888) 396-8049 and the confirmation number is 47314692. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call.

Use of Non-GAAP Financial Measures

ViewRay reports its financial results in accordance with generally accepted accounting principles in the United States ("GAAP") and the rules of the SEC. To supplement its financial statements prepared and presented in accordance with GAAP, ViewRay uses adjusted EBITDA as a non-GAAP financial measure.

ViewRay has supplemented its GAAP net loss with a non-GAAP measure of adjusted EBITDA. We define adjusted EBITDA as EBITDA (defined as net income before net interest expense, depreciation, and amortization), adjusted for impairment of assets, non-cash equity-based compensation, non-cash changes in warrant liability valuations, and non-recurring costs.

Management believes that this non-GAAP financial measure provides useful supplemental information to management and investors regarding the performance of the company and facilitates a meaningful comparison of results for current periods with previous operating results. Management uses adjusted EBITDA for both strategic and annual operating planning.

Adjusted EBITDA has important limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. Some of these limitations are that Adjusted EBITDA:

does not reflect any charges for the assets being depreciated and amortized that may need to be replaced in the future;
does not reflect the significant interest expense or the cash requirements necessary to service interest or, if any, principal payments on our debt;
does not reflect the impact of write-downs of long-lived assets;
does not reflect the impact of share-based compensation upon our results of operations;
does not reflect the impact of changes in fair value of our warrant liabilities; and
does not include certain expenses that are non-recurring, infrequent and unusual in nature.
A reconciliation of GAAP net loss (the most directly comparable GAAP measure) to non-GAAP adjusted EBITDA is provided in the schedules below.

On February 27, 2023 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will host a conference call and live webcast on Tuesday, February 28, 2023, at 8:30 a.m. Eastern Time to report its fourth quarter and full-year 2022 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, FEB 27, 2023, View Source [SID1234627772]).

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A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.

On February 27, 2023 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its fourth quarter and full year 2022 financial results on Monday, March 6, 2023. The Company will host a conference call at 4:30pm ET on the same day (Press release, Cyclacel, FEB 27, 2023, View Source [SID1234627771]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference call information:

Participant Toll-Free Number: 800-245-3047 Primary

Participant Direct/International Number: 203-518-9765 Alternate

Code for live and archived conference call is CYCCQ422. Webcast Link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On February 27, 2023 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, reported that company management will participate in a corporate panel discussion and 1×1 investor meetings at the Cowen 43rd Annual Health Care Conference, which is taking place at the Boston Marriott Copley Place from March 6 – 8, 2023 (Press release, Cardiff Oncology, FEB 27, 2023, View Source [SID1234627770]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details of the panel discussion can be found below.

GI/GU Oncology Panel Discussion

Date:

Tuesday, March 7, 2023

Time:

Webcast Link:

12:50 PM ET

Here

A replay of the panel discussion will be available by visiting the "Events" section of the Cardiff Oncology website and will be archived for 30 days following the completion of the conference.

On February 27, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported that it will host a key opinion leader (KOL) webinar at 8 a.m. EST on Tuesday, February 28, 2023, to discuss the results from the recently completed pivotal Phase 3 SIERRA trial of Iomab-B, which were presented in a late-breaker presentation at the Transplantation & Cellular Therapy (TCT) tandem meetings on February 18, 2023 (Press release, Actinium Pharmaceuticals, FEB 27, 2023, View Source [SID1234627769]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Sergio A. Giralt, MD, currently serves as Deputy Division Head, Division of Hematologic Malignances, the Melvin Berlin Family Chair in Multiple Myeloma and Chief Medical Officer, MSK Direct at Memorial Sloan Kettering Cancer Center and is a Professor of Medicine at Weil Cornell Medical College. Dr. Giralt will discuss the unmet medical needs of older patients with active Relapsed or Refractory Acute Myeloid Leukemia (r/r AML), along with the practice changing potential for Iomab-B in this patient population. The event will highlight the potential for Iomab-B, a first-in-class targeted radiotherapy, to improve access to potentially curative bone marrow transplants for these patients who are not considered viable for this procedure.

A live question and answer session will follow the formal presentations. To register for the event, please click here or visit the investor relations page of Actinium’s website here.

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are honored that Dr. Giralt, who is instrumental in advancing the field of bone marrow transplant, will present the SIERRA data and frame how Iomab-B can address the unmet need for the majority of r/r AML patients who are not transplantable today. We are excited to move ahead with the BLA filing of Iomab-B in 2H:2023 following the highly positive, full results from the SIERRA trial which clearly established Iomab-B’s ability to provide unprecedented access to a BMT to patients who currently not transplantable and to meaningfully improve outcomes. Additionally, we are enthused by the other consequential milestones we intend to achieve in 2023 including moving Actimab-A into late-stage development following our recent CRADA with the NCI, additional data and important studies with Iomab-ACT, the Early Access Program for Iomab-B and progress with our earlier stage solid tumor programs. Our current balance sheet of approximately $100 million (unaudited) is expected to fund operations through 2025 and will allow us to continue to create value from these important milestones and provide clarity on how Actinium could radically alter the treatment of r/r AML with Iomab-B and Actimab-A and dramatically improve outcomes".

Sergio Giralt, MD, is a board-certified hematologist-oncologist, and his clinical activity and research focus is on stem cell transplantation for patients with blood disorders. He trained and worked for many years at the University of Texas M.D. Anderson Cancer Center, where he was Deputy Chair of the Department of Stem Cell Transplantation and Cellular Therapies. In May 2010, Dr. Giralt joined the faculty of Memorial Sloan Kettering Cancer Center to lead the Adult Bone Marrow Transplant Service and currently serves as Deputy Division Head, Division of Hematologic Malignances, the Melvin Berlin Family Chair in Multiple Myeloma and Chief Medical Officer, MSK Direct. He is an Attending Physician, Adult Bone Marrow Transplant Service at MSKCC and Professor of Medicine at Weil Cornell Medical College.

Dr. Giralt’s research focus has been on improving treatments for older patients who have acute and chronic leukemia. Along with his colleagues, he pioneered the use of reduced-intensity conditioning regimens for older or more debilitated patients with blood cancers which has changed the standard of care throughout the world. Dr. Giralt’s research interests span the continuum of transplant and cellular therapy and include T-cell depletion techniques to reduce the risk of graft-versus-host disease. He is a also a proponent of post-transplant maintenance therapies using a variety of targeted therapies, which they are continuing to explore at Memorial Sloan Kettering. Dr. Giralt recently chaired the executive board of the Center for International Blood and Marrow Transplant Research. He is also the past chair of the steering committee of the Blood and Marrow Transplant Clinical Trials Network, a federally funded group that defines the research agenda for stem cell transplantation in the United States.

To register for the event, please click here or visit the investor relations page of Actinium’s website here.

About Iomab-B and the Pivotal Phase 3 SIERRA Trial

Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative BMT by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45. Multiple studies have demonstrated increased survival in patients receiving BMT, however, an overwhelming majority of patients with blood cancers do not receive BMT as current approaches do not produce a remission, which is needed to advance to BMT, or are too toxic. Studied in over 400 patients, prior studies with Iomab-B have demonstrated nearly universal access to BMT, increased survival and tolerability in multiple clinical trials including the recently completed pivotal Phase 3 SIERRA trial in patients with active (leukemic blasts >5%), relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above.

Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6 months after initial remission post-BMT in the pivotal Phase 3 SIERRA trial with high statistical significance (p<0.0001). Iomab-B produced a 75% post-BMT CR rate (44/59 patients), which is 12-times greater than the post-BMT rate of 6.3% (4/64 patients) in the control arm. Patients receiving Iomab-B had a 78% lower probability of an event, defined as not achieving a CR/CRp, crossover, not receiving a BMT, relapse or death, with a Hazard Ratio of 0.22 (p<0.0001). Iomab-B doubled 1-year overall survival with 26.1% compared to 13.1% in the control arm for patients who did not crossover as well as median overall survival with 6.4 months vs 3.2 months. Overall survival statistics are confounded by the crossover arm. Crossover patients had a 35.8% 1-year overall survival rate. Due to its targeted nature, Iomab-B was well tolerated with four times lower rates of sepsis compared to the control arm (6.1% vs. 28.6%) and lower rates of BMT associated adverse events including febrile neutropenia, mucositis and graft versus host disease (GVHD). Actinium intends to submit a Biologics License Application (BLA) seeking approval for Iomab-B in 2023 to address patients age 55+ with r/r AML who cannot access BMT with currently available therapies. Iomab-B has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and has patent protection into 2037.

The pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly relapsed or refractory AML) is a 153-patient, randomized, multi-center clinical trial, studying Iomab-B compared to the control arm of physician’s choice of salvage therapy. Control arm options included chemotherapies like cytarabine and daunorubicin and targeted agents such as a Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors. The SIERRA control arm reflects real-world treatment of r/r AML patients with over 20 agents used alone or in combination as no standard of care exists for this patient population. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada that perform over 30% of AML BMTs.

Developed at the Fred Hutchinson Cancer Research Center, a pioneer in the field of BMT, Iomab-B is supported by data in six disease indications including leukemias, lymphomas and multiple myeloma, which afflict over 100,000 patients annually. Actinium intends to pursue additional indications for Iomab-B beyond AML. Actinium also intends to pursue international regulatory approvals independently and through partnerships. In April 2022, Actinium licensed the European, Middle East and North African commercial rights for Iomab-B to Immedica AB, a fully-fledged independent pharmaceutical company headquartered in Sweden. In exchange, Actinium received an upfront payment of $35 million USD with the potential for an additional $417 million USD in regulatory and sales milestones and mid-twenty percent royalties. Europe represents a commercial opportunity double the size of the United States by number of patients with AML receiving BMT. Iomab-B has been granted Orphan Drug Designation by the European Medicines Agency (EMA) and has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.